| ISO 9394 Third edition 2012-10-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 10-77 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | J. Angelo Green FDA/OMPT/CDRH/ODE/DOED/CLRD/ 301-796-6860 angelo.green@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.5928 | Accessories, Soft Lens Products | Class 2 | LPN |
| §886.5928 | Accessories, Solution, Ultrasonic Cleaners For Lenses | Class 2 | LYL |
| §886.5928 | Case, Contact Lens | Class 2 | LRX |
| §886.5928 | Sterilizer, Soft-Lens, Thermal, Ac-Powered | Class 2 | HRD |
| §886.5928 | Sterilizer, Soft-Lens, Thermal, Battery-Powered | Class 2 | HRC |
| §886.5925 | Lens, Contact, (Disposable) | Class 2 | MVN |
| §886.5925 | Lens, Contact, For Color Vision Deficiency | Class 2 | NCZ |
| §886.5925 | Lens, Contact, For Reading Discomfort | Class 2 | NIC |
| §886.5925 | Lenses, Soft Contact, Daily Wear | Class 2 | LPL |
| §886.5925 | Lenses, Soft Contact, Extended Wear | Class 3 | LPM |
| §886.5925 | System, In-Office Tinting, Contact Lenses | Class 2 | MZD |
| §886.5918 | Products, Contact Lens Care, Rigid Gas Permeable | Class 2 | MRC |
| §886.5916 | Lens, Contact (Orthokeratology) | Class 2 | MUW |
| §886.5916 | Lens, Contact (Other Material) - Daily | Class 2 | HQD |
| §886.5916 | Lens, Contact (Rigid Gas Permeable), Extended Wear | Class 3 | MWL |
| §886.5916 | Lens, Contact, Orthokeratology, Overnight | Class 3 | NUU |
| Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994 Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997 |